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A study to evaluate the dose-response effect of tolvaptan 7.5mg or 15mg in HF patients who undergo cartdiac angiography

A study to evaluate the dose-response effect of tolvaptan 7.5mg or 15mg in HF patients who undergo cartdiac angiography - A study to evaluate the dose-response effect of tolvaptan 7.5mg or 15mg in HF patients who undergo cartdiac angiography

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000009924
Enrollment
100
Registered
2013-02-01
Start date
2013-01-04
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Heart Failure

Interventions

Tolvaptan 15mg Tolvaptan 7.5mg

Sponsors

Showa University Northern Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: (1)Heart failure patients who undergo cardiac angiography (2)ability of oral administration (3)male or female subjects over 20 years of age at the time of informed consent (4)ability to provide written informed consent (5)eGFR<60

Exclusion criteria

Exclusion criteria: (1)history of allergy against this drug or similar compounds (2)anuria (urine volume <100ml/day) (3)subjects who cannot feel thirsty or have difficulty to drink (4)subjects whose serum sodium level is over 147mEq/L (5)subjects who are pregnant or possibly pregnant (6)subjects who already have tolvaptan at the entry (7)acute coronary syndrome (8)patients who are judged to be inappropriate to this study

Design outcomes

Secondary

MeasureTime frame
(1)Renal injury at 48h after the procedure (Percent changes of serum creatinine /CysC/BNP/urinary albumin) (2) Major post-procedure in-hospital adverse clinical events, including cardiogenic shock, clinically significant arrhythmia, CIN requiring renal replacement therapy (hemofiltration or homodiafiltration), pulmonary edema, and death

Primary

MeasureTime frame
Frequency of contrast-induced nephropathy within 48 hours after the administration of radiocontrast agents

Countries

Japan

Contacts

Public ContactKennosuke Yamashita

Showa University Northern Hospital Division of cardiology and Cardiovascular Surgery

045-949-7000

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026